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Trial record 99 of 163 for:    ISOTRETINOIN

Bioequivalence Study of V0057 Versus a Reference Formulation After Single Administration in Healthy Male Subjects

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ClinicalTrials.gov Identifier: NCT01861626
Recruitment Status : Completed
First Posted : May 23, 2013
Last Update Posted : June 19, 2013
Sponsor:
Information provided by (Responsible Party):
Pierre Fabre Dermatology

Brief Summary:
The purpose of this study is to evaluate the bioequivalence (comparison of the rate and extent of the active substance into the body following single administration of the drugs) between the test product V0057 and a reference product after two single oral administration separate by 7 days.

Condition or disease Intervention/treatment Phase
Healthy Volunteers Drug: V0057 - A mg Drug: Isotretinoin Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 45 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : May 2013
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
sequence 1 : Test drug - Reference Drug: V0057 - A mg
Single oral administration

Drug: Isotretinoin
Single oral administration

Sequence 2 : Reference - Test drug Drug: V0057 - A mg
Single oral administration

Drug: Isotretinoin
Single oral administration




Primary Outcome Measures :
  1. Maximum Plasma Concentration (Cmax) [ Time Frame: 18 time points up to 72h after administration ]
  2. Time of Maximum Concentration (Tmax) [ Time Frame: 18 time points up to 72h after administration ]
  3. Area under curve (AUC0-72) [ Time Frame: 18 time points up to 72h after administration ]


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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy male subject aged 18 to 50 years (inclusive)

Exclusion Criteria:

  • Presence of any significant medical finding or significant history that may impact the safety, the interpretation of the results and/or the participation of the subject in the study according to the opinion of the investigator
  • Presence of any clinically significant abnormal finding at examination in the Investigator's opinion

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01861626


Locations
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Germany
Erfurt, Germany, D-99084
Sponsors and Collaborators
Pierre Fabre Dermatology

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Responsible Party: Pierre Fabre Dermatology
ClinicalTrials.gov Identifier: NCT01861626     History of Changes
Other Study ID Numbers: V00057 CA 1 01
2013-000988-80 ( EudraCT Number )
First Posted: May 23, 2013    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: June 2013
Additional relevant MeSH terms:
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Isotretinoin
Dermatologic Agents